510(k) K161634 ยท LLZ System, Image Processing, Radiological
IPS CaseDesigner
| Applicant | Nobel Biocare AB, Goteborg, SE |
| Decision | Substantially Equivalent, Nov 10, 2016 |
| Received | Jun 14, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161634
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.